Memantine Hydrochloride Extended-Release, Capsules, 7 mg

The Harvard Drug Group LLC has recalled Memantine Hydrochloride Extended-Release, Capsules, 7 mg, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on April 22, 2026 and was initiated on March 24, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Memantine Hydrochloride Extended-Release, Capsules, 7 mg, with approximately N/A affected. The company behind the recall is The Harvard Drug Group LLC, based in Dublin, OH. The FDA describes the product as: “Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61”

Why was Memantine Hydrochloride Extended-Release, Capsules, 7 mg recalled?

According to the FDA, the stated reason for the recall is: “Failed Dissolution Specifications.” In plain terms, this recall relates to a potency or effectiveness issue.

This recall means the medicine may be stronger or weaker than its label says, or may not release its ingredient the way it should. That matters because too little medicine may not treat the condition, and too much can cause side effects. Anyone taking an affected product is generally advised to consult their pharmacist or doctor about a replacement.

What should you do?

If you think you may have bought Memantine Hydrochloride Extended-Release, Capsules, 7 mg, compare it against the product description and identifying codes (Lot # N02425, Exp Date: 05/31/2027.) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact The Harvard Drug Group LLC or your local health authority.

About this recall

This recall was distributed in OH. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.